COPD stable period
Conditions
Interventions
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
Male
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria of western medicine for chronic obstructive pulmonary disease; 2. Outpatients with moderate to severe lung function in compliance with GOLD; 3. In line with patients with high risk of acute exacerbation; 4. Comply with the syndrome differentiation standard of spleen and kidney yang deficiency and phlegm-drinking obstructing lung syndrome; 5. Aged from 40 to 80 years; 6. Agree to participate in this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Accompanied by asthma, active tuberculosis, lung cancer, bronchiectasis, pulmonary embolism, pulmonary heart disease, pulmonary interstitial disease or other active diseases; 2. Patients with AECOPD or infection within 1 month before the consultation; 3. Patients who need long-term oxygen therapy (daily oxygen inhalation time >=12h) or patients undergoing pulmonary rehabilitation; 4. Pneumonectomy in the past, or lung volume reduction surgery within 12 months before screening; 5. Those suffering from severe hypertension, heart failure, arrhythmia, diabetes, tumors, and unsatisfactory control of primary heart, liver, kidney, and blood system diseases; 6. Kidney Scr exceeds the upper limit of the reference value by 1.5 times, or the liver function test AST, ALT >=2 times the upper limit of the reference value; 7. Those with known or suspected history of alcohol or drug abuse; 8. Pregnant or lactating women or those planning to become pregnant during the study period; 9. Those who are allergic to the ingredients of the study drug and those who are not suitable for use in the instructions; 10. Those who have participated in other clinical trials within the past 3 months; 11. Those who are judged by the investigator to be unsuitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time of first AECOPD attack; | — |
Secondary
| Measure | Time frame |
|---|---|
| The severity of the first AECOPD;Number of AECOPD attacks;TCM syndrome integral;Cough, phlegm, and dyspnea score (BCSS);Lung function (FEV1, FVC, FEV1/FVC);The CAT score;MMRC dyspnea score;6 minutes walking distance;Immunological indicators(CD4+, CD8+, CD4+/CD8+, IgA, IgG, IgM);Inflammatory factors(IL-6, IL-8, IL-15, TNF-a and CRP);Adrenocortical function(serum cortisol, 24-hour urine 17-hydroxycorticosteroid, 24-hour urine 17-ketone steroid); | — |
Countries
China
Contacts
Public ContactWen Fuqiang
West China Hospital of Sichuan University
Outcome results
None listed